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- FDA reverses earlier stance, grants uniQure accelerated approval pathway for Huntington's gene therapyOn June 17, 2026, the U.S. Food and Drug Administration issued a second reversal, allowing biotech company uniQure to pursue an accelerated approval pathway for its gene therapy targeting Huntingto…
- FDA approves first generic single-dose baloxavir tablet for flu treatment and preventionFDA announced approval of the first generic version of Xofluza (baloxavir marboxil) tablets, a single-dose treatment for acute uncomplicated influenza and prophylaxis for patients five years of age…